MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-06 for CHILDREN'S MEDICAL VENTURES * 96004-N manufactured by Philips Children's Medical Ventures.
[22249063]
Concern for potential harm to infant when membrane on pacifier comes out (small hole located in middle of pacifier dislodges). Potential for aspiration. ======================manufacturer response for soothie newborn pacifier, children's medical ventures (per site reporter). ======================contacted rep and order number was given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4755195 |
| MDR Report Key | 4755195 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-05-06 |
| Date of Event | 2015-05-05 |
| Report Date | 2015-05-06 |
| Date Reported to FDA | 2015-05-06 |
| Date Reported to Mfgr | 2015-05-07 |
| Date Added to Maude | 2015-05-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHILDREN'S MEDICAL VENTURES |
| Generic Name | SOOTHIE NEWBORN PACIFIER |
| Product Code | LQX |
| Date Received | 2015-05-06 |
| Model Number | * |
| Catalog Number | 96004-N |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS CHILDREN'S MEDICAL VENTURES |
| Manufacturer Address | 191 WYNGATE DRIVE MONROEVILLE, PA 15146 US 15146 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-06 |